Primary Objective: Does long-term endocrine adjuvant treatment for breast cancer lead to structural changes in the brain and to functional changes in brain-wide networks, and do these changes correlate with cognitive impairment induced by the…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neuropsychological measures that quantify cognitive functioning, and parameters
derived from brain imaging methods (MEG and fMRI).
Secondary outcome
n.a.
Background summary
Cognitive impairment is frequently reported by breast cancer patients during
adjuvant endocrine treatment and has an important negative impact on quality of
life and treatment adherence. Identification of functional changes in the brain
that lead to cognitive dysfunction in breast cancer patients can not only serve
a theoretical understanding of this important side effect, but can also provide
an objective biological marker supporting the diagnosis. This may eventually
lead to new treatment options for cognitive dysfunction. Also, the development
of biological markers which correlate with a patient*s susceptibility to
cognitive changes may help to identify patients at risk for cognitive
impairment and thus help to individualize adjuvant endocrine treatment.
Study objective
Primary Objective: Does long-term endocrine adjuvant treatment for breast
cancer lead to structural changes in the brain and to functional changes in
brain-wide networks, and do these changes correlate with cognitive impairment
induced by the treatment? Secondary Objective(s): Do pre-treatment structural
and dynamic properties of brain-wide networks predict treatment induced
cognitive impairment?
Study design
Observational, longitudinal study.
Study burden and risks
The experimental protocol will exist of neuropsychological tests, an MEG
measurement, and an (f)MRI measurement. The total duration is approximately 3.5
hours. The subjects will be measured twice at an interval of ~6 months.
Considering the extensive exclusion criteria, the screening procedure, and
constant monitoring of the subjects we do not expect (S)AE side effects. MEG
and MRI measurements themselves do not pose any risk, if appropriate
precautions are taken. The noise and the relative confined space of the MRI
scanner may cause discomfort to some subjects. MEG measurements are silent and
take place in a less confined space, and are even less likely to cause
discomfort.
postbus 9101
6500 HB
NL
postbus 9101
6500 HB
NL
Listed location countries
Age
Inclusion criteria
* Women of age * 18 years.
* Histologically/cytologically confirmed adenocarcinoma of the breast followed by intended curative surgery and if indicated, also radiotherapy and chemotherapy.
* ER + and/or PgR + receptor status.
* Indication for treatment with tamoxifen or anastrozole according to the Dutch guidelines.
* Disease-free, as defined by the absence of somatic disease activity parameters.
* Accessible for follow-up for duration of study.
* Karnofsky 80-100.
* Written informed consent.
Exclusion criteria
* Palliative treatment or inflammatory breast cancer .
* Evidence of distant metastasis (M1).
* Concomitant or previous malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.
* Hormone Replacement Therapy for treatment of menopausal symptoms, not stopped at least 4 weeks prior to inclusion in the study.
* Current psychological or psychiatric treatment.
* Treatment with anti-depressive drugs, anti-epileptic drugs, benzodiazepines.
* Insufficient command of the Dutch language to fill out questionnaires.
* Contra-indication for MR examinations (e.g. claustrophobia).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39165.091.12 |